title: Walking performance and health-related quality of life after surgical or endovascular invasive versus non-invasive treatment for intermittent claudication--a prospective randomised trial.
abstract: OBJECTIVE
  Despite limited scientific evidence for the effectiveness of invasive treatment for intermittent claudication (IC), revascularisation procedures for IC are increasingly often performed in Sweden. This randomised controlled trial compares the outcome after 2 years of primary invasive (INV) versus primary non-invasive (NON) treatment strategies in unselected IC patients.
  
  
  METHODS
  Based on arterial duplex and clinical examination, IC patients were randomised to INV (endovascular and/or surgical, n = 100) or NON (n = 101). NON patients could request invasive treatment if they deteriorated during follow-up. Primary outcome was maximal walking performance (MWP) on graded treadmill test at 2 years and secondary outcomes included health-related quality of life (HRQL), assessed with Short Form (36) Health Survey (SF-36).
  
  
  RESULTS
  MWP was not significantly (p = 0.104) improved in the INV versus the NON group. Two SF-36 physical subscales, Bodily Pain (p < 0.01) and Role Physical (p < 0.05) improved significantly more in the INV versus the NON group. There were 7% crossovers against the study protocol in the INV group.
  
  
  CONCLUSIONS
  Although invasive treatment did not show any significant advantage regarding MWP, the HRQL improvements associated with invasive treatment tentatively suggest secondary benefits of this regimen. On the other hand, a primary non-invasive treatment strategy seems to be accepted by most IC patients.
authors.affiliation: Department of Vascular Surgery, Sahlgrenska University Hospital, Sweden. joakim.nordanstig@vgregion.se
authors.forename: J
authors.initials: J
authors.lastname: Nordanstig
authors.forename: J
authors.initials: J
authors.lastname: Gelin
authors.forename: M
authors.initials: M
authors.lastname: Hensäter
authors.forename: C
authors.initials: C
authors.lastname: Taft
authors.forename: K
authors.initials: K
authors.lastname: Österberg
authors.forename: L
authors.initials: L
authors.lastname: Jivegård
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D057510:Endovascular Procedures; D005080:Exercise Test; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D040242:Risk Reduction Behavior; D011795:Surveys and Questionnaires; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014656:Vascular Surgical Procedures; D016138:Walking
chemical_list: D002317:Cardiovascular Agents